Qualified Person

Ipsen Biopharm Ltd; Wrexham; On-site; GBP 65,000 - 90,000; Full time

Job summary

Ipsen Biopharm Ltd. in Wrexham seeks an experienced Qualified Person to lead batch certification and release, ensuring compliance with UK/EU GMP and Annex 16. You will partner with manufacturing, QA and regulatory teams to uphold product quality and patient safety.

The role requires a scientific degree, eligibility as a Qualified Person, and strong experience in pharmaceutical quality systems and sterile manufacturing. On-site work at the Wrexham site is required.

Qualifications

• Degree (or equivalent) in a relevant scientific discipline.
• Fluent written and spoken English.
• Eligible to act as a Qualified Person under UK/EU regulations.
• Significant pharmaceutical industry experience, ideally within sterile manufacturing and Quality Assurance.

Responsibilities

• Certify and release finished product batches in line with EU/UK GMP and Annex 16, per Quality Technical Agreements.
• Confirm compliance of intermediate manufacturing stages, personally or with other Ipsen QPs.
• Lead and support timely batch disposition for commercial and clinical products; escalate quality risks as needed.
• Provide quality leadership across manufacturing, product development and regulatory activities.
• Drive continuous improvement initiatives to enhance compliance and site quality performance; support regulatory inspections and audits.

Skills

GMP knowledge

English proficiency

Quality Assurance

Leadership

Education

Degree in Chemistry/Pharmacy/Biology/Biochemistry

Job description

Title: Qualified Person

Company: Ipsen Biopharm Ltd

About Ipsen: Ipsen is a mid‑sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation. Our passionate teams in more than 40 countries are focused on what matters and endeavour every day to bring medicines to patients in 88 countries. We build a workplace that champions human‑centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society! For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram.

Job Description

Join Our Award‑Winning Team at Ipsen Wrexham At Ipsen, we are driven by one purpose: improving patients’ lives through innovative medicines. Our Wrexham site plays a critical role in delivering high‑quality sterile pharmaceutical products to patients across the UK and EU. We are proud to be Great Place to Work® certified and a Shingo Bronze Medallion holder, reflecting our strong culture of excellence, continuous improvement and collaboration. With a £24m recent investment and a further £86.4m site expansion underway, there has never been a more exciting time to join Ipsen Wrexham. If you are an experienced Qualified Person who is passionate about quality, leadership and making a real impact on patient safety, we would love to hear from you.

Role Summary

As a Qualified Person, you will be named on both the Ipsen Wrexham MIA and IMP licences and play a critical leadership role in ensuring that medicinal products are manufactured and released in full compliance with UK and EU regulatory requirements. You will act as a key quality leader on site, supporting both commercial and clinical activities, driving a strong “Commitment to Quality” culture, and partnering closely with manufacturing, technical and supply teams to ensure compliant, timely batch disposition.

In this role you will:

• Certify and release finished product batches in line with EU/UK GMP and Annex 16, in accordance with Quality Technical Agreements
• Confirm compliance of intermediate manufacturing stages, either personally or through collaboration with other Ipsen QPs
• Lead and support timely batch disposition for commercial and clinical products, escalating quality risks where required
• Provide quality leadership and expert input across manufacturing, product development and regulatory activities
• Drive continuous improvement initiatives to enhance compliance, efficiency and site quality performance
• Act as a subject matter expert during regulatory inspections, internal audits and partner interactions
• Serve as a key point of contact for CMO and affiliate GMP quality matters
• Mentor and support the Quality Operations team, acting as a role model for quality‑first decision making

What We’re Looking For

Essential:

• Degree (or equivalent) in a relevant scientific discipline (e.g. Chemistry, Pharmacy, Biology, Biochemistry)
• Eligible to act as a Qualified Person under UK/EU regulations
• Significant pharmaceutical industry experience, ideally within sterile manufacturing and Quality Assurance
• Strong working knowledge of GMP requirements, including Annex 1 and Annex 16
• Fluent written and spoken English

Desirable:

• Previous experience being named on an IMP licence
• Strong sterile manufacturing expertise
• Lean, Six Sigma or other continuous improvement qualifications
• Lead Auditor qualification

What We Value At Ipsen, how we work is just as important as what we deliver. We are looking for someone who demonstrates:

• A strong patient and customer focus
• Confidence in mindful risk‑based decision making
• The ability to operate effectively in ambiguous or complex environments
• A collaborative mindset, building strong partnerships across functions
• A genuine commitment to quality, integrity and continuous improvement

Working at Ipsen Wrexham

Working style: Fully on‑site

Collaboration: Work closely with Manufacturing, QC, QA, MS&T and Supply Chain

Culture: Inclusive, supportive and improvement‑driven

Impact: Direct contribution to patient safety and product quality

Why Join Ipsen?

• Be part of a highly invested, expanding manufacturing site
• Work in an organisation recognised for operational excellence and people culture
• Influence quality strategy and decision making at site and global level
• Make a meaningful difference to patients’ lives every day

We are committed to creating a workplace where everyone feels heard, valued, and supported; where we embrace “The Real Us”. The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities. When we include diverse ways of thinking, we make more thoughtful decisions and discover more innovative solutions. Together we strive to better understand the communities we serve. This means we also want to help you perform at your best when applying for a role with us. If you require any adjustments or support during the application process, please let the recruitment team know. This information will be handled with care and will not affect the outcome of your application.

At Ipsen, each employee makes a real impact. Our teams are passionate about what they do because they care about making a difference in patients' lives. We invest in our employees to support life‑changing projects that create positive impact for patients and society.